Kornimate/medical-research-clean huggingface dataset:
a prospective observational study of effect of somatropin on growth hormone deficient adults

Conditions: Hypopituitarism; Pituitary Insufficiency; Growth Hormone Deficiency, Adult

Summary: the hypopituitary control and complications study "hypoccs" is a prospective, open label, global, multicentre, observational study on routine clinical care of adults with growth hormone deficiency occurring either isolated or in combination with other pituitary hormone deficiencies. the objective of this observational study is to evaluate long-term safety and health outcomes for adult growth hormone deficient participants with or without somatropin replacement therapy. as an observational study, data are collected only as provided at the discretion of the attending physician. the participant enrolled meet the criteria of growth hormone deficiency in adults as per the humatrope label in the country where their attending physician practices, and this diagnosis is at the discretion of the attending physician. the decision to receive somatropin or remain untreated is made by the participant in consultation with their attending physician. while treatment of adult growth hormone deficient participants with somatropin has been shown to be safe and effective in clinical trials of 18 months duration, this observational study aims to provide information on health outcome and replacement therapy over longer periods of time for a larger number of participants in the context of the overall disease environment.


Eligibility criteria:
inclusion criteria: - adult growth hormone deficiency as per the local humatrope label and as judged by the attending physician exclusion criteria: - as per the local humatrope label and as judged by the attending physician
18f-flt (pet/ct) in pediatrics with myeloproliferative neoplasms

Conditions: Essential Thrombocythemia; Primary Myelofibrosis, Fibrotic Stage; Primary Myelofibrosis, Prefibrotic Stage; Polycythemia Vera

Summary: the main purpose of this project to study the uptake pattern of flt-pet and it is value in assessing the malignant hematopoiesis in mpn within the pediatric age group, in terms of diagnosis, staging and monitoring response to therapy. as well as, evaluating flt-pet as a novel non-invasive technique in cases with mpn and its role in comparison to the standard bone marrow biopsy with regard to disease diagnosis, assessment of disease activity, detection of transformation, monitoring of treatment response and grading of fibrosis.furthermore, we aim to study the association of flt-pet uptake patterns with different genetic makeup (jak2, calr positive, mpl, or triple negative disease) or allele burden in cases of pre-pmf with the ability of flt-pet to differentiate between pre-pmf and et. although mpns are diseases of elderly, mpn is diagnosed in younger age groups in a considerable number of cases. since most of the available data as well as current who classification criteria emphases on the "average" mpn patients who range in age between 55 and 65 years. less consistent data are available in the groups of patients presenting below this median age, such as children and younger adults which we're planning to reveal.


Eligibility criteria:
inclusion criteria: * cases fulfilling who (world health organization) 2016 diagnostic criteria for mpn including: chronic myeloid leukemia, bcr-abl1-positive (bcr-abl = fusion gene from bcr (breakpoint cluster region gene/bcr gene product), chronic neutrophilic leukemia (cnl), polycythemia vera, primary myelofibrosis prefibrotic/early stage, primary myelofibrosis overt fibrotic stage, essential thrombocythemia, chronic eosinophilic leukemia, not otherwise specified (nos) and myeloproliferative neoplasm, unclassifiable. * age between 14 and 18 years old * patient accepts to sign inform consent * ecog (eastern cooperative oncology group) performance less than or equal 2 exclusion criteria: * patient not fulfilling the inclusion criteria. * vulnerable groups: pregnant, minors, prisoners will not be included.
feasibility trial of extracorporeal iron purification in patients with myelodysplastic syndrome or myelofibrosis

Conditions: Myelodysplastic Syndrome; Myelofibrosis

Summary: in transfusion-dependent myelodysplastic syndromes patients, regular blood transfusions lead to iron overload, which can cause organ damage, hormonal imbalances, and increased infection risk, ultimately impacting patient survival. standard oral iron chelation therapies can be intolerable for some patients due to adverse effects. the mex-cd1 device (class iii) could potentially offer an alternative for these patients by reducing serum iron levels through a novel, extracorporeal approach. mexiron clinical investigation focuses on the use of mex-cd1, a medical device designed for extracorporeal chelation therapy to reduce serum iron overload in patients suffering from transfusion-dependent myelodysplastic syndromes (mds) and myelofibrosis. mexiron aims to evaluate the device's use feasibility, safety, and effectiveness in reducing serum free iron levels. transfusions needs, patient experience and quality of life are also assessed. each enrolled patients will undergo three low-volume continuous veno-venous haemodialysis cycles within one week. following the three- haemodialysis cycles, patients will be monitored through on-site follow-up visits at 7 days, 28 days, and 90 days post-treatment to assess long-term effects.


Eligibility criteria:
inclusion criteria: * patient followed for myelodysplastic syndrome or myelofibrosis. * patient with platelet count ≥50 giga/l at inclusion. * patients with severe anemia and hemoglobin \<70 g/l at baseline. * patient with intolerance or contraindication to oral or subcutaneous chelation therapy. * ferritinemia \>1000 µg/l or hepatic iron concentration ≥7 mg/g or cardiac t2\* \<20 ms at inclusion. * patient able to understand (french-speaking) and comply with protocol, having signed informed consent. exclusion criteria: * patients with primary hemochromatosis (transferrin saturation coefficient cs-tf \> 45%). * patients with a contraindication to the use of mex-cd1: weight \< 30 kg, iron deficiency. * patients with a known allergy or contraindication to heparin or citrate. * patients undergoing azacitidine or other chemotherapy (or considered as such) for myelodysplastic syndrome or myelofibrosis. * patients with indications for allogeneic bone marrow transplantation. * patients with a known allergy to shellfish (mex-cd1 contains chitosan of animal origin) or to one of the other components of mex-cd1. * patients with a peripheral vascular access that is difficult to access or that needs to be preserved. * patients participating in other interventional research that could interfere with the results of the study. * patients under legal protection or unable to express their consent. * patients under psychiatric care. * patient deprived of liberty by judicial or administrative decision. * pregnant or breast-feeding women.

Keywords: myelodysplastic syndrome myelofibrosis iron chelation therapy haemodialysis
contingency management to promote weight loss in low income adults

Conditions: Overweight

Summary: this study is designed to evaluate the feasibility and provide preliminary evidence for efficacy of a 12-week contingency management intervention to promote weight loss in overweight and obese low income adults in a community-based clinic. the study has three primary goals: (a) to determine if the contingency management treatment can be effectively applied to a new application, weight loss; (b) to obtain preliminary evidence for contingency management's efficacy in promoting weight loss and improving treatment retention, diet quality, physical activity levels, and self efficacy; and (c) to identify barriers and challenges to implementing contingency management for weight loss among low income patients.


Eligibility criteria:
inclusion criteria: * age between 18 and 55 years * body mass index in kg/m2 (bmi) between 25 and 39.9 * resting blood pressure between 90/60 and 140/90 * ability to speak english and read at the 6th grade level * willingness to be randomly assigned to one of two groups exclusion criteria: * any serious acute or chronic medical problems that may impact dietary or exercise regimens * psychiatric conditions

Keywords: overweight obesity contingency management
evaluation of the gore® excluder® iliac branch endoprosthesis

Conditions: Common Iliac Artery Aneurysms; Aorto-iliac Aneurysms

Summary: the iliac branch endoprosthesis (ibe) 12-04 study will be a prospective, nonrandomized, multicenter, single-arm evaluation designed to assess the safety and efficacy of the ibe device in subjects with common iliac artery aneurysms (ciaa) or aorto-iliac aneurysms (aia).


Eligibility criteria:
inclusion criteria: 1. common iliac aneurysm with or without concomitant abdominal aortic aneurysm 2. adequate native anatomy to receive the excluder® and iliac branch endoprostheses 3. an informed consent form signed by subject or legally authorized representative 4. male or infertile female 5. able to comply with protocol requirements including following-up 6. life expectancy \> 2 years 7. age \> 21 years 8. surgical candidate exclusion criteria: 1. mycotic or ruptured aneurysm 2. known concomitant thoracic aortic aneurysm which requires intervention 3. american society of anesthesiologists (asa) physical status classification system class v (moribund patient not expected to live 24 hours with or without operation) 4. renal insufficiency defined or patient undergoing dialysis 5. new york heart association (nyha) functional classification class iv 6. dissected, heavily calcified, or heavily thrombosed landing zone(s) 7. tortuous or stenotic iliac and/or femoral arteries 8. participating in another investigational device or drug study within 1 year of treatment 9. systemic infection which may increase the risk of endovascular graft infection 10. known degenerative connective tissue disease, e.g., marfan or ehler-danlos syndrome 11. planned concomitant surgical procedure or major surgery within 30 days of treatment date 12. known history of drug abuse 13. known sensitivities or allergies to the device materials
behavioral therapy of obstetric sphincter tears

Conditions: Fecal Incontinence

Summary: the study design will be a cohort study to determine the incidence of fi symptoms at 6, 12 and 24 weeks postpartum in primiparous women sustaining an oasi. at 6, 12 and 24 weeks postpartum, subjects will be contacted by telephone for evaluation of fi symptoms. symptoms of fi will be defined by at least monthly symptoms of leakage of liquid, solid stool, and mucus. flatal incontinence will be assessed at 24 weeks, based on the fecal incontinence severity index, and fecal urgency will be assessed at 24 weeks based on the one question from the modified manchester questionnaire. a sample size of approximately 400-450 subjects will be enrolled.

the primary aim of the "boost cohort study" is to determine the incidence of fi symptoms at 6 and 12 weeks postpartum in primiparous women sustaining an oasi. secondary aims of the cohort study are: 1. to determine the incidence rates of fi symptoms at 24 weeks post delivery in primiparous women sustaining an oasi 2. to examine the relationship between the modified who sphincter tear classification types and fi symptoms 3. to examine predictors (socio-demographic, physical and clinical) associated with who sphincter tear classifications (3a, 3b and 4) and predictors associated with fi symptoms 4. to evaluate the incidence of fecal urgency and flatal incontinence at 24 weeks postpartum in primiparous women sustaining an oasi.

Eligibility criteria:
inclusion criteria assessed by 2 weeks postpartum 1. vaginal delivery \>= 28 weeks singleton gestation 2. documented repair to the anal sphincter at delivery 3. first vaginal delivery 4. ambulatory 5. able to give informed consent 6 adult women \>= 18 years of age inclusion criteria at 2 weeks postpartum 1. inflammatory bowel disease (e.g., ulcerative colitis or crohn's disease) 2. pre-pregnancy ano-rectal surgery (e.g., surgery for hemorrhoids, fissures, sphincterotomy) 3. pre-pregnancy fi (defined as the leakage of liquid/solid stool and mucus \>= once per month for at least 12 weeks prior to this pregnancy) 4. neurological condition that would predispose to fi (e.g., spinal cord injury, multiple sclerosis) 5. presence of rectovaginal fistula 6. any participation in other pharmacologic or behavioral studies for fi 7. previous pregnancy \>=28 weeks delivered vaginally or by cesarean section

Keywords: fecal incontinence, bowel incontinence, pelvic floor disorder
the prevalence of a low ankle-brachial index in acute cerebral ischemia.

Conditions: Ischemic Stroke

Summary: aim of the study is assessment the prevalence of the low ankle-brachial index (abi) defined less than or equal 0.9 in patients with acute cerebral ischemic event (stroke or transient ischemic attack) and determinate the correlation between abi and internal carotid artery stenosis (icas) in the acute cerebral ischemic patients. the low abi is a strong marker of generalized atherosclerosis. lead is a strong independent predictor for stroke.

aim of the study is assessment the prevalence of the low ankle-brachial index (abi) defined less than or equal 0.9 in patients with acute cerebral ischemic event (stroke or transient ischemic attack) and determinate the correlation between abi and internal carotid artery stenosis (icas) in the acute cerebral ischemic patients. the abi is a non-invasive tool useful for the diagnosis of lead. the low abi is a strong marker of generalized atherosclerosis. lead is a strong independent predictor for stroke. significant icas is prevalent among patients having lead. acute ischemic stroke due to significant icas has poor prognosis. patients with lead may be a suitable subgroup for screening for icas using duplex scanning. estimating the relationship between cerebral ischemic event and the abi value could help better guide preventive and risk reduction strategies.

Eligibility criteria:
inclusion criteria: * acute ischemic stroke or transient ischemic attack of anterior circulation * consent of patient exclusion criteria: * primary intracranial hemorrhage, * venous sinus thrombosis, * unconsciousness, * intubation, * inability to provide and write a consent application form.

Keywords: ischemic stroke tia abi lead
effect of performance-specific cleft speech intervention and long-term learning in children with a cleft palate

Conditions: Cleft Palate Children; Speech Disorders in Children; Cleft Lip and Palate; Speech Therapy

Summary: speech therapy in children with a palate deals with two scientific challenges that will be addressed in this project. the first challenge is selecting the best speech approach for a child with a specific cleft speech characteristic (csc). many speech therapists use a 'one-size-fits-all' approach to treat compensatory cscs resulting in poor short- and long-term speech outcomes. to increase the effectiveness and quality of cleft speech care, it is necessary to find the best match between a specific therapy and a given type of csc. therefore, this proposal will compare the effect of 3 different speech approaches on the speech and quality of life in dutch speaking children with different types of cscs. the second challenge is selecting the best speech approach to enhance long-term learning and transfer of newly established speech skills to untrained consonants. to date, research mainly focused on immediate therapy effects. it is unknown if permanent speech changes occur. hence, this project will also investigate the short-term and long-term learning effects (retention and transfer) of the different speech approaches from the first objective. this proposal will improve evidence-based and patient-tailored cleft speech therapy.

objective 1: to compare the (immediate) effect of three speech therapy approaches (i.e. a motor-phonetic approach, a phonological approach, and a combined phonetic-phonological approach) on the speech and health-related quality of life (hrqol) in belgian dutch-speaking children with a cp±l and different subtypes of compensatory cscs (anterior oral cscs, posterior oral cscs, or non-oral cscs) measured by perceptual and psychosocial outcome measures. objective 2: to measure the short-term effects (performance to learning) and the long-term learning effects (retention and transfer) of the three different speech therapy approaches (i.e. a motor-phonetic approach, a phonological approach, and a combined phonetic-phonological approach) on the speech and hrqol in belgian dutch-speaking children with a cp±l and different subtypes of compensatory cscs measured by perceptual and psychosocial outcome measures.

Eligibility criteria:
inclusion criteria: * belgian dutch-speaking children with a cleft palate with or without a cleft lip * aged between 4 and 12 years * presence of at least one compensatory speech error in their speech based on the perceptual assessment of one experienced speech-language pathologist exclusion criteria: * children with syndromic clefts * oronasal fistula * velopharyngeal insufficiency * hearing disabilities based on pure tone audiometry (\>25 db hl) * cognitive and/or related learning disabilities or neuromuscular disorders

Keywords: randomized controlled trial speech therapy cleft lip and palate
expression of molecular markers in circulating tumor cells of metastatic castration-resistant prostate cancer

Conditions: Prostate Cancer Metastatic

Summary: as prostate cancer progresses into castration-resistant stage from initial hormone-sensitive status, the biological behavior of tumor cells that dissociated from primary lesions changed. considered a "liquid biopsy," these circulating tumor cells (ctcs) can show how a patient's cancer responded to treatments. the purpose of this study is to determine whether sequentially analyzing the expression of molecular markers in high volume circulating tumor cells in metastatic castration-resistant prostate cancer patients can predict the therapeutic effects and outcomes of these patients.


Eligibility criteria:
inclusion criteria: 1. male patients 2. 18 yrs and older, and 80 yrs and younger 3. histologically or cytologically proven prostate adenocarcinoma; 4. imaging examinations including emission computed tomography (ect), positron emission tomography (pet) and so on revealed a high-volume disease of patients(a high-volume of disease was defined by the presence of visceral metastases or four or more bone lesions with at least one beyond the vertebral bodies and pelvis) 5. have been received hormonal therapy and progressed into castration-resistant stage 6. not yet receiving chemotherapy 7. patients are willing to participate and can be followed up regularly exclusion criteria: 1. received the treatment of abiraterone acetate previously 2. patients received chemotherapy previously 3. combined with other malignant tumor history (in addition to the skin basal cell carcinoma or other tumors that have been cured more than five years).

Keywords: metastatic castration-resistant prostate cancer circulating tumor cells prognosis liquid biopsy
internet-based reiki for tinnitus 2021

Conditions: Tinnitus

Summary: the objectives of the study will be 1) to develop and show the feasibility of an internet-based reiki therapy as an intervention for tinnitus, 2) to deliver reiki therapy for tinnitus as a potential treatment, 3) to maintain a meaningful cohort of participants over a 6-month protocol, and 4) to collect pilot data on the potential benefit of internet-based reiki therapy on tinnitus-related quality of life. patients will also be provided with information on other potential tinnitus therapies.

reiki is a wellness practice of energy healing that began in japan and is now practiced throughout the world. the principle of reiki is that everything in the universe consists of energy including the human body, and deviations of this energy can lead to disease. reiki does not have a religious doctrine and is accepted by people of all backgrounds and belief systems. reiki is considered by practitioners to be a great tool for stress reduction and relaxation (international association of reiki practitioners). many people use reiki for wellness. reiki is not a cure for a disease or illness, but it may assist the body in creating an environment to facilitate healing. according to the center for reiki research, reiki is an effective approach for reducing pain, depression, and anxiety. tinnitus is a pain percept, and it is likely reiki may reduce pain and anxiety in patients with tinnitus. the aims of the study are to show the feasibility of an internet-based reiki therapy as an intervention for tinnitus. home based therapy can reduce the stress of receiving therapy in an unfamiliar environment. home-based therapy can also allow the participants to regain more control their surroundings, making them more likely to benefit from relaxation and stress relief benefits of reiki. specific aim 1: the first aim is to show that our reiki therapy can be delivered to tinnitus patients on an internet-based platform this aim will be achieved if the investigators can recruit patients into the study and deliver internet-based therapy over the 6 months of the protocol while retaining a meaningful 30 percent of our cohort. specific aim 2: the second aim is to show that participants perceive a benefit from the therapy protocol. this aim will be studied by retaining a meaningful cohort of participants and by analyzing data from the questionnaire results for the tinnitus handicap inventory (thi) and tinnitus functional index (tfi) before treatment, at 3 months and after 6 months of treatment and comparing them to the participants' baseline questionnaires. data from the questionnaires will be used to determine sample size needed for a larger blinded control study.

Eligibility criteria:
inclusion criteria: * english or spanish speaking patients with unilateral or bilateral tinnitus exclusion criteria: * people under the age of 18 * people without internet access

Keywords: tinnitus reiki